Greater Bern Area
I am instrumental in review, adapt, and monitor implementation of IT policies. With over 21 years in pharmaceutical industry, I have aptitude to review and approve deviations, corrective and preventative actions, and change controls. I have ability to understand the industry best practices, evaluate trends and continuously monitor market development. I am expert in formulating, implementing, and periodically updating the global product group’s strategy and targets for operations and OPEX/CAPEX in accordance with the business line-strategy and targets. I have capacity to lead strategic distribution discussions and transform future requirements into distribution network planning activities. I am influential in participating and coordinating with internal teams for process harmonization, governance, and execution of projects.
Contribute to the creation and implementation of best practice quality vision, strategy, policies, processes and procedures to aid and improve operational performance. Develop and execute the quality management vision and strategy in alignment with the manufacturing site vision and strategy. Ensure operational excellence culture, methodology and activities within quality management organization. Lead the implementation of DocuSign for GxP documents across the company. Key Contributions: • Streamlined and enhanced operational efficiency by directing and developing operational excellence culture, methodology, and activities within the QM department. • Created and managed the implementation of lean processes for validation and stability teams with a total savings of 5 FTE. • Oversaw and organized the strategic portfolio of projects and initiatives involving Quality Management (QM), including specification and visualization of the related governance structure, timelines, investments, and benefits. • Supported regulatory reportable changes across the enterprise by implementing the faster change implementation project.
Provided leadership and support to CSL affiliates operations to ensure implementation and maintenance of appropriate, operationally efficient quality systems. Represented CSL affiliate in key global quality projects. Maintained strong communication between the manufacturing sites and global functions within CSL and CSL affiliates. Increased operational performance by driving continuous improvement and efficiency initiatives. Key Contributions: • Reduced operational costs and expenditures by implementing deviation and CAPA management systems across the affiliates on time with no CAPEX or OPEX funding. • Assisted the successful strategic implementation of new CSL Behring affiliates offices in Turkey and Chile. • Spearheaded the implementation of Quality systems across 30 countries ahead of schedule and under budget. • Implemented Plateau and GDRS systems across the Affiliates ahead of schedule and with 30% under budget. • Improved customer response time by 50% through development and implementation of effective product technical compliant management system. • Delivered timely products and avoided potential fine through collaboration with ComOps across different manufacturing sites.
Oversaw daily operational support and improvement of 5 direct reports that managed and supported 6 GxP applications, including usage of ITQMS to support software upgrade and changes. Maintained and strengthened relationship with stakeholders to carry out best possible benefits. Key Contribution: • Designed financial budgeting and forecasting OPEX and CAPEX for a team of 3 and Regulatory Information Management System (RIMS) Project Management of approximately $1.8M. • Designed, evaluated, tested and implemented RIMS application across the manufacturing sites and the affiliates on time. • Supported IT harmonization and business processes improvement on time by delivering the One CSL IT program.